Periodic Reporting for period 1 - Calypso (The next-generation heart pump to change patients’ lives and create a new standard of care) Reporting period: 2020-10-01 to 2021-09-30 Summary of the context and overall objectives of the project Heart failure (HF) is a deadly pandemic, affecting 11 million Europeans, with a prognosis worse than most cancers. Currently, cardiac pumps (or "LVADs", left ventricular assist devices) for patients with advanced HF are based on rotary technology, which creates a constant blood flow. As a result, patients with LVADs have no pulse, which is highly disturbing to the body's physiology. Despite the good survival rates of patients with LVADs, their overall quality of life is strongly affected by severe adverse events (stroke, etc.) and restrictions of daily activities.To help HF patients return to a fully active life, CorWave develops an LVAD based on a proprietary breakthrough technology. CorWave LVAD is a biomimetic pump that uses a membrane mimicking the undulating motion of marine animals. With this unique technology, CorWave LVAD intends to fully respect the patient's physiology, reduce adverse events, and remove current daily limitations.Through the EIC Accelerator project, CorWave’s objective is to complete the preclinical work and validate clinically CorWave LVAD. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far CorWave is currently in pre-clinical testing. In this regard:- CorWave recently achieved a technical milestone in a chronic preclinical in vivo study, representing a world first in LVADs. CorWave LVAD operated for 90 days in pulsatile mode by synchronizing with the native heart. The study also confirmed the excellent hemocompatibility of the CorWave pump.- Regarding fatigue performance, a key characteristic of LVADs, CorWave's studies on test benches have exceeded 12 months.Besides, to support CorWave's structuration in its industrial production phase and upcoming clinical trials, the company has succeeded in attracting two international LVAD experts as VP, RAQACA, and VP, Manufacturing. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) CorWave has made outstanding progress towards the objectives set for the EIC Accelerator project: complete the preclinical part of the CE Marking technical file and conduct the European clinical trial.Based on a breakthrough proprietary technology, CorWave must go beyond the state of the art to deliver the safest, most beneficial LVAD to HF patients and clinicians. To predict the hemocompatibility and hemodynamic performance of different pump designs, CorWave has developed unique simulation tools. The synchronous pulsatility algorithm, which was successfully tested in the recent 90-day in vivo study, is also groundbreaking.CorWave aims at making a major impact on the treatment of advanced HF patients by offering them excellent survival and improved quality of life. Decreasing rehospitalizations should also reduce the cost of LVAD therapy and improve its adoption, allowing more patients to benefit from this life-saving therapy.CorWave will also have wider societal impacts, such as a socioeconomic one with job creations, and a scientific one with major progress on mechanical fluid simulations and hydraulic bench testing. CorWave LVAD
